This is a leading company in the orthopedic trauma market. They develop, manufacture and market the AO ASIF system of internal fixation instruments and implants used by surgeons to repair difficult bone fractures. This concept was developed in Switzerland by Professors Maurice Müller, Martin Allgöwer, Robert Schneider and Hans Willenegger, who realized that conventional methods of fracture treatment (plaster casts) often led to poor results and partial disability. These surgeons, along with a group of metallurgists and scientists, formed the Swiss group known as the AO (Arbeitsgemeinschaft fur Osteosynthesefragen) ASIF (Association for the Study of Internal Fixation). The resulting system of carefully conceived stainless steel and titanium implants to hold fracture ends in precise alignment while healing takes place has revolutionized orthopaedic surgery and saved countless patients from varying degrees of disability. The AO products were originally produced and distributed by Mathys Medical and Straumann (later Stratec Holdings). This USA company was formed in 1974 and began marketing the AO ASIF system in North America in 1975. Early in 1999, said company and another company together agreed to merge into one company serving the orthopedic, spinal, maxillofacial and veterinary surgical specialties in North and South America and Europe. In 2004, this company continued its globalization with acquisition of Mathys Medical AG, to become the sole producer of AO ASIF instruments and implants, with the opportunity to serve surgeons in every corner of the world. Being a global leader in the orthopaedic trauma market and has expanded from its roots in orthopaedic trauma to include maxillofacial and spine surgery. The Maxillofacial division designs and markets products for use in mandible, orthognathic and cranial surgery, providing treatments for trauma applications and reconstructive surgery. They have developed surgical techniques and instrument and implant systems to treat deformity and degenerative disorders of the spine, as well as spinal trauma. Fantastic company with a great chance to move up. Great benefits too Job Title: Quality Assurance Engineer - BioMaterials Job Requirements: This is one perm position located at the Development Center. The salary could be anywhere from $55 to $80K plus a bonus potential up to $7,750. Relocation is available for the right candidate. Candidates must have Biomaterials experience. Will be working with a five person QA team in Biomaterials. OVERALL RESPONSIBILITIES: Develop, implement and maintain Quality System requirements on assigned areas of Manufacturing, Supplier management, Process Validation and New Products Introduction. Areas of responsibility may include: Non-conforming product, CAPA, Calibration Systems, Supplier Auditing, Sterility, Measuring techniques, Design of tools and gages, Training, Statistical Support, Quality Planning, Experimental Protocols, Facilitation of Root Cause analysis, Risk Assessment and Complaint Investigation. POSITION DUTIES & RESPONSIBILITIES: General • Know and follow all laws and policies that apply to one’s job and maintain the highest levels of professionalism, ethics and compliance at all times. • Diligently participate in our compliance program- related activities as denoted by your supervisor or our Chief Compliance Officer. • Perform other related duties as required. The Quality Engineer assignments can be isolated but not limited to the following tasks: Manufacturing Support • Member of the Material Review Board (MRB). Communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions. • Work on continuous improvement activities. These may include participating in, and/or leading Quality Improvement Teams. • Provide quality reports and review trending on assigned areas of responsibility. • Conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, supplier quality issues, calibration out of tolerance conditions, and CAPA’s (internal or audit CAPA’s ). • Review and approve documents and drawings for manufacturing and product development (DCO’s, MC’s). • Support to Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of new and existing products. • Develop training course materials and conduct training for approved documentation and practices. New Products • Participate on cross- functional project teams. • Design gauging and develop tools and techniques to measure pertinent product parameters to assure product complies with engineering drawings. • Recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities. • Develop and document Quality Plans to support new products. • Facilitate creation of PFMEA. • Ensure compliance issues are addressed for new products activities. • Participate on design reviews and risk analysis for new products. Validation • Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness. • Review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval. • Provide guidance to others for the generation of clear, concise and defendable protocols and reports. • Assist in determination of the need for validation. • Generate and/or maintain internal validation master plans as required. • Manage process monitoring activities including tracking, data collection and analysis, corrective action, and reporting. • Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s). • Lead continuous improvement activities for the validation program to ensure efficiency, effectiveness and compliance. Supplier Management • Coordinate and participate on supplier audits and technical assessments. • Assist purchasing with identification and qualification of suppliers and alternate manufacturing locations. • Administrate Supplier Management Program and measures effectiveness. • Manage Supplier CAPA activities including root cause analysis, definition of corrective actions and verification of actions. • Coordinate Quality Plans and inspection/test methods between suppliers. • Visit suppliers for the purpose of quality issues investigation and capability analysis. • Assist purchasing in resolution of supplier complaints. PROFESSIONAL EXPERIENCE & EDUCATIONAL REQUIREMENTS: BS degree in Sciences, Business, Engineering or related technical field. Experience in the medical and/or pharmaceutical field. Two (2) years QE experience preferred. Knowledge of FDA’s QSR and ISO regulations preferred. Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development. Strong Statistical ability and experience including Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments. ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification preferred. Demonstrated excellent interpersonal and communication skills. Working knowledge of Word Processing and Spreadsheet software required (MS Word and Excel knowledge desired). Knowledge of Manufacturing materials and processes preferred (machining, sheet metal, electropolishing, passivation, hard coating, anodizaton, etc.) Attention to detail and ability to meet deadlines. Ability to manage multiple projects/requirements in a fast-paced environment. Ability to work independently with minimum supervision for application of QE principles and Techniques. Ability to work effectively in a team environment. DEVELOPMENT CENTER ONLY REQUIREMENTS: Knowledge of Manufacturing Clean Rooms, ISO Class 7 and ISO Class 8 (Class 100,000 and 10,000). Strong environmental monitoring knowledge for Clean rooms. Experience with Biomaterial, Ceramic and Polymer medical devices is a plus. Strong Pharma/Medical Device Manufacturing and R&D experience. Knowledge of sterile packaging and sterilization validations. Location: WESTCHESTER, PA Compensation: (In Job Posting) Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests. delaware